Certain diseases, conditions, surgeries, procedures, and medications are associated with malabsorption of fat, which can lead to serious deficiencies of the fat-soluble vitamins D, E, K, and A. For example, individuals suffering from cholestatic liver disease, cystic fibrosis, Crohn's Disease, post-bariatric procedures, and many other conditions may experience severe deficiencies of vitamins D, E, K, and A.
Supplementation with standard multi-vitamins often fails to correct serious deficiencies associated with malabsorption of fat. First, standard multi-vitamins often fail to provide doses of vitamins D, E, K, and A of sufficient strength to correct deficiencies resulting from malabsorption of fat. Second, standard multivitamins generally contain additional vitamins other than vitamins D, E, K, and A (such as selenium, zinc, copper, and iron), such that increasing the dose of the multivitamin to deliver enough of vitamins D, E, K, and A results in toxicity of one or more other vitamins or minerals contained in the multivitamin formula. Third, fat-soluble vitamin deficiency cannot be corrected in certain conditions only by increasing the dosage and requires the use of technology to facilitate absorption.
The need exists to develop a scalable vitamin formulation comprising vitamins D, E, K, and A, wherein the composition unit dosage is scalable based on weight, age, and condition of a subject, without inducing adverse toxic effects.